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QUALITY ENGINEER

 

Company:

INTEGRA LIFESCIENCES
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Job Reference Number

14564675

Client ID:

RI/1090138410IRE
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Posted On:

Feb 2 2012

Location:

OFFLAY, OFFALY
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Job Type:

Permanent

Salary:

.
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Benefits:
  • TRAINING / EDUCATION
  • CAR PARKING
  • PENSION / PRSA
  • PERM. HEALTH INSURANCE
  • LIFE ASSURANCE
JOB DESCRIPTION

Job Title: QA ENGINEER

Department: Quality

Location: Tullamore (Ireland)

Contract Type: Permanent Full-Time

Effective Date: 06th December 2011

1. SUMMARY DESCRIPTION

Key role of this position is to proactively support engineering activities with regards to product robustness changes and compliance related projects, ensuring technical correctness, and compliance with requirements of global regulations. This is an essential function in the overall strategy for improved assurance of delivered product quality and continuity of established QMS and to support growth of the Company.

2. ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

  • Working in conjunction with Engineering Department, co-develop design verification & validation protocols for new products (or transfer) and for change on existing products, conduct design verification & validation studies, review and approve protocols, studies, and perform general oversight responsibilities for validation process, for both equipment and processes.
  • Key member of New Product Introduction teams, both working in conjunction with Product Development and Tullamore Engineering Depts, for process and product understanding and technical assessment.
  • Member of Engineering Peer Review of design approach, layouts, worst case best case analysis, tolerance stack-up, design architecture, regulatory compliance, and assessing supporting documentation.
  • Working with other Integra site/s, project manage for this site, QMS alignment to ensure compliance continuance to allow for duality of manufacture of product, as part of business risk mitigation initiative.
  • Approve alternate components, assuring compliance with relevant product safety files, and International regulatory / material usage requirements.
  • Review Engineer's Log Books for technical completeness, accuracy, and address of identified design inputs with associated demonstrable outputs.
  • Collate and trend quality data relating to product robustness, conduct analysis and recommend necessary technical solutions to drive effective corrective action.
  • Conduct detailed root cause analysis on design related non conformances, developing effective preventive measures to prevent recurrence.
  • Review MDHA and D-FMEA updates with RC / RA Dept, on new product or product changes, mitigating risk and controlling compliance to Risk Management and cGMP requirements.
  • Support P-FMEA activities with QA and or Process Engineering group.
  • Provide technical support for new product transfers from other Integra facilities, writing Quality Plans, and monitoring status of executables to ensure smooth transition into established QMS at Tullamore.
  • Champion DFM and DFT approaches with the engineering group, aiming for Lean and 6 Sigma manufacturing.
  • Working with Corp Reliability dept to ensure products attain expected life expectancy aligned with market expectations, MTBF calculations and published data.
  • Ensure that requirements laid down in the Quality Manual and Standard Operating Procedures are adhered too, and provide advice and guidance on quality related aspects.
  • Conduct Internal Audits against schedule as part of Audit Team.
  • Work closely with QA/RA Manager to effect roll-out of new Quality Initiatives and Corporate SOPs.


3. QUALIFICATIONS/EXPERIENCE

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
  • Degree level in Electronics Engineering.
  • Minimum 3-5 years experience at Quality Engineering level within a FDA or ISO 13485 cGMP regulated medical device manufacturer, preferably in electronics or electro-mechanical based devices
  • Excellent working knowledge of ISO 13485 and 21CFR820, along with exposure to other foreign Regs
  • Hands-on experience with product and process validation protocols and studies
  • Experience in internal auditing to QSRs
  • Working familiarity with ISO 14971: 2007 and IEC 60601 a distinct advantage


4. PERSONAL COMPETENCIES
  • Good project planning and organizational abilities.
  • Strong interpersonal and communications skills, including oral and written reports.
  • Pro-active with proven ability to work under own initiative, and strong team player.
  • Solid technical ability.
  • Wiliness to travel to other Integra sites as part of duties.


5. DISCLAIMER

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description is subject to change as the needs of the business and requirements of the job change.